SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.
Eligibility criteria
Qualifiers
Type 2 Diabetes Mellitus
Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) <50%
Age 18-80 years
BMI 23-38 kg/m2
Disqualifiers
Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
Pregnancy, lactation or plans to become pregnant
Allergy/sensitivity to study drugs or their ingredients
Cancer
Trial design
Treatments tested in this trial
- Empagliflozin 25 MG
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
1University of Texas Health Science Center at San Antonio78229, San AntonioTexas, United States
Sponsors and collaborators
The University of Texas Health Science Center at San Antonio
Lead sponsor
Doris Duke Charitable Foundation
Collaborator
Max and Minnie Tomerlin Voelcker Fund
Collaborator
Source ClinicalTrials.gov